6919 Kangpei*

Release Date: 1150728 Statement Date: 1150727 Statement Time: 172605 Company Code: 6919 Company Name: Kangpei* Subject: Today, we completed the submission of an Investigational New Drug (IND) application to the U.S. FDA for a multicenter Phase 2 clinical trial of our new drug CBL-514 injection in combination with tirzepatide (Eli Lilly) for reducing abdominal subcutaneous fat in overweight or obese adults. Compliance Clause: Clause 10 Event Date: 1150727 Details: 1. Event Date: 115/07/27 2. Name or Code of the Investigational Drug: CBL-514 3. Indications: A. Reduce subcutaneous fat B. Improve moderate to severe cellulite C. Treat the rare disease Cushing's syndrome D. Reduce subcutaneous fat in overweight or obese adults 4. All Planned Stages of Development: A. Phase 1 Clinical Trial: Completed. B. Phase 2 Clinical Trial: Application submitted. C. Phase 3 Clinical Trial: Not yet initiated. D. New Drug Application (NDA) Review: Not yet initiated. 5. Current Stage of Development (Please specify whether the current stage is application submitted/approved/not approved. If not approved, describe risks and mitigation measures. Also describe future business direction and cumulative R&D expenses incurred): (1) Application submitted/approved/not approved/results of human trials (including interim analyses)/other major events affecting drug development: The multicenter Phase 2 clinical trial CBL-0201WR of our investigational drug CBL-514 injection in combination with tirzepatide (Eli Lilly) for reducing abdominal subcutaneous fat in overweight or obese adults was completed on July 27, 2026, with the submission of the IND application to the U.S. FDA. This trial uses MRI to measure changes in abdominal subcutaneous fat volume as the efficacy endpoint and plans to enroll 120 participants in the United States. A. Clinical Trial Design (including trial name, objective, phase classification, drug name, claimed indication, evaluation metrics, and number of enrolled participants): a. Trial Name: A randomized, placebo-controlled Phase 2 clinical trial to evaluate the efficacy, safety, and tolerability of CBL-514 injection in combination with tirzepatide for reducing abdominal subcutaneous fat in overweight or obese adults. b. Objective: To evaluate the efficacy, safety, and tolerability of CBL-514 injection in combination with tirzepatide for reducing abdominal subcutaneous fat in overweight or obese adults. c. Phase Classification: Phase 2 Clinical Trial d. Drug Name: CBL-514 e. Claimed Indication: Reduction of abdominal subcutaneous fat in overweight or obese adults f. Evaluation Metrics: Primary efficacy endpoint is the change in abdominal subcutaneous fat volume measured by MRI g. Number of Enrolled Participants: 120 participants planned B. Statistical results of primary and secondary endpoints (including but not limited to p-values) and their statistical significance (including whether statistical significance was achieved). If the company cannot disclose statistical data due to other significant reasons, please explain: Not applicable C. If statistical data from Phase 3 human clinical trials (including interim analyses) become available, describe future plans for market entry (note: content should avoid triggering requirements for financial forecasts under the company's 'Standards for Full Financial Projections Required for Public Companies'): Not applicable. D. Results from a single clinical trial (including p-values and statistical significance of primary and secondary endpoints) are insufficient to fully reflect the success or failure of future drug development and commercialization. Investors should carefully assess and invest prudently. (2) Risks and mitigation measures the company faces if not approved by the relevant regulatory authority, if clinical trial results (including interim analyses) do not achieve statistical significance, or if other major events affecting drug development occur: Not applicable. (3) Future business direction if approved by the relevant authority, if clinical trial results achieve statistical significance, or if other major events affecting drug development occur: Under company evaluation. (4) Cumulative R&D expenses incurred: Not disclosed at this time to protect company and investor interests and in consideration of future marketing strategies. 6. Next stage of development to be conducted (please specify expected completion date and expected obligations): (1) Expected completion date: Adjusted according to actual clinical trial progress. (2) Expected obligations: None. 7. Market Overview: The claimed indication for CBL-0201WR IND is the reduction of abdominal subcutaneous fat in overweight and obese adults, spanning two rapidly growing and highly underserved markets: 'localized fat reduction' and 'weight management'. Current localized fat reduction methods include invasive surgical procedures and non-invasive treatments. While surgical methods offer more noticeable results, they involve significant tissue and nerve damage, high risk, and long recovery periods. Marketed non-surgical fat reduction products have limited efficacy, often requiring repeated treatments and potentially causing severe side effects or irreversible risks. Due to these limitations, consumers and patients face a dilemma between 'effective but risky' and 'safe but ineffective' options, creating urgent demand for a new generation of localized fat reduction therapies that are both safe and fundamentally effective. Meanwhile, the global weight management market is rapidly expanding due to the rise of GLP-1 class drugs, with the focus shifting from 'significant weight loss' to 'reducing more fat, maintaining weight after discontinuation, and metabolic health'. GLP-1 drugs achieve weight loss by suppressing appetite, resulting in only 'temporary shrinkage' of fat cells, without reducing their 'number'. Their ability to improve stubborn fat deposits in the abdominal subcutaneous area and other regions is limited. After prolonged use, as the body's energy metabolism adapts, weight loss tends to plateau, leading to diminishing marginal efficacy. Once the drug is discontinued and appetite returns, the shrunken fat cells preferentially reabsorb energy, rapidly expanding and proliferating, accompanied by visceral fat accumulation and increased insulin resistance, creating a 'double crisis' of 'weight rebound' and 'deterioration of body composition'—an unresolved challenge in current weight management. As weight management needs become increasingly diverse, obesity treatment has evolved from a single weight metric to include fat distribution adjustment, body composition improvement, and healthy weight loss. Market consensus is becoming clearer: the next generation of therapies must reduce fat cell numbers at the root, rather than merely suppressing appetite or shrinking fat volume. CBL-514 strategically targets both markets—directly reducing the number of abdominal subcutaneous fat cells to fundamentally address localized fat, while also enabling synergistic combination with GLP-1 class drugs to further clear stubborn fat on top of weight loss, effectively maintain weight after discontinuation, improve body composition, and prevent rebound and metabolic deterioration. This dual action simultaneously addresses the pain points of the localized fat reduction market for safe and effective therapies and the urgent needs of the weight management market for post-discontinuation weight maintenance and body composition quality, positioning CBL-514 as a potentially complementary first-choice therapy in both fields and filling a critical gap in the current treatment pathway. 8. Other Matters to be Disclosed (If the entity involved in the event or resolution is a publicly traded company, this material information also meets the criteria under Article 7, Clause 8 of the Enforcement Rules of the Securities and Exchange Act regarding matters having significant impact on shareholder rights or stock prices): None. 9. Drug development involves long timelines, high investment, and no guarantee of success, which may expose investors to risks. Investors should carefully assess and invest prudently.